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2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Elbow, Hemi-, Radial, Polymer

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §888.3170 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Prosthesis, Elbow, Hemi-, Radial, Polymer LIGHT-BOOK · MAUDE

#526 of 1000 · 1,793 reports · 1993–2026

  • BOOK 1,793 reports
  • RANK #526 of 1000
  • DEATH 3 death-typed
  • INJ 1,557 injury-typed
  • MALF 210 malfunction
  • SPAN 1993–2026
  • PEAK 2017: 360
  • PHOTO Needle

Nearest event-volume peer: Needle, Aspiration And Injection, Disposable (3 report gap)

Prosthesis, Elbow, Hemi-, Radial, Polymer sits #526 of 1000 among tracked device types with 1,793 MAUDE reports spanning 1993–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports run above the device-type norm

Prosthesis, Elbow, Hemi-, Radial, Polymer carries 86.8% INJURY-coded reports, 56.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 86.8% corpus 30.3% · above corpus mean (+56.5 pp)
  • MALF 11.7% corpus 64.8% · below corpus mean (-53.1 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 23% of coded problems · Lead manufacturer SYNTHES MONUMENT accounts for 18% of manufacturer-tagged reports · Top event location I is 61% of location-tagged rows .

Prosthesis, Elbow, Hemi-, Radial, Polymer in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Prosthesis, Elbow, Hemi-, Radial, Polymer carries 1,793 MAUDE reports, ranked #526 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 1,557 (86.8%)
Malfunction 210 (11.7%)
Other 21 (1.2%)
Death 3 (0.2%)
2 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 1,047 (50.5%)
Other 308 (14.8%)
R 228 (11.0%)
Hospitalization 227 (10.9%)
200 (9.6%)
H 44 (2.1%)
O 8 (0.4%)
Death 6 (0.3%)
S 3 (0.1%)
L 2 (0.1%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 409
Unintended Movement 200
Insufficient Device Problem Information 122
Device Slipped 109
Loose or Intermittent Connection 103
Device Dislodged or Dislocated 101
Detachment Of Device Component 85
Detachment of Device or Device Component 80
Explanted 76
Loosening of Implant Not Related to Bone-Ingrowth 76
Material Separation 66
Migration or Expulsion of Device 59
Appropriate Device Problem Term/Code Not Available 54
Unstable 50
Break 45
Fracture 38
Device Operates Differently Than Expected 29
Migration 27
Osseointegration Problem 24
Replace 24

Yearly Trend

93
1993: 1
94
1994: 1
95
1995: 1
96
1996: 1
97
1997: 6
98
1998: 2
99
1999: 7
00
2000: 5
01
2001: 7
02
2002: 5
03
2003: 18
04
2004: 15
05
2005: 5
06
2006: 7
07
2007: 15
08
2008: 16
09
2009: 14
10
2010: 13
11
2011: 10
12
2012: 16
13
2013: 31
14
2014: 29
15
2015: 103
16
2016: 138
17
2017: 360
18
2018: 202
19
2019: 214
20
2020: 118
21
2021: 44
22
2022: 44
23
2023: 77
24
2024: 124
25
2025: 121
26
2026: 23

Reports in 2025 (121) held close to the prior two-year average of 101.

Related Entities for Prosthesis, Elbow, Hemi-, Radial, Polymer

Top Manufacturers

SYNTHES MONUMENT 195
ZIMMER BIOMET, INC. 189
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 167
STRYKER GMBH 132
BIOMET ORTHOPEDICS 126
WRIGHT MEDICAL TECHNOLOGY INC 94
WRIGHT MEDICAL TECHNOLOGY, INC. 91
SYNTHES USA 61

Event Locations

I 1,089 (60.7%)
589 (32.8%)
HOSPITAL 99 (5.5%)
NO INFORMATION 7 (0.4%)
UNKNOWN 4 (0.2%)
AMBULATORY SURGICAL FACILITY 3 (0.2%)
OTHER 2 (0.1%)

Compare SYNTHES MONUMENT vs ZIMMER BIOMET, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis, Elbow, Hemi-, Radial, Polymer: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,793 here).

Needle, Aspiration And Injection, Disposable 1,796 Operating Room Accessories Table Tray 1,802 System, Ablation, Microwave And Accessories 1,784 Over-The-Counter Automated External Defibri… 1,803

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Prosthesis, Elbow, Hemi-, Radial, Polymer are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Prosthesis, Elbow, Hemi-, Radial, Polymer; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.